Cleared Traditional

K962202 - QUANTEX IGG

K962202 is the FDA 510(k) clearance for QUANTEX IGG by Instrumentation Laboratory CO. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K962202 · Instrumentation Laboratory CO · Immunology device
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Sep 1996
Decision
111d
Days
Class 2
Risk

K962202 is an FDA 510(k) clearance for the QUANTEX IGG. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 26, 1996 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K962202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1996
Decision Date September 26, 1996
Days to Decision 111 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 104d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 39
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K962202.
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
K963974 · Beckman Instruments, Inc. · Mar 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · Beckman Instruments, Inc. · Mar 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
K963868 · Beckman Instruments, Inc. · Feb 1997
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
K955798 · Randox Laboratories, Ltd. · Apr 1996
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL
K951635 · Beckman Instruments, Inc. · May 1995
BEHRING NEPHELOMETER II
K943997 · Behring Diagnostics, Inc. · Oct 1994